The present invention relates to probes insertable into a body cavity for various purposes, as will be described more particularly below, and also to a method of utilizing such a probe for the various purposes described below.
The invention may be used to apply any combination of electrical stimulation, pressure biofeedback, and microcirculation biofeedback for therapeutic purposes as well as to make measurements of pelvic floor muscular and vascular impairments. The therapeutic purposes include treating for impairments or dysfunsctions of the neuro-muscular, neuro-vascular, peripheral vascular systems associated with bladder and fecal incontinence, disuse atrophy and weakness of the pelvic floor musculature, pelvic pain, erectile dysfunction, and orgasm.
It is well know to apply electrotherapy over the pelvic floor surface, or within the vagina or rectum, in order to improve, ameliorate or prevent impairments of the pelvic floor such as muscle disuse atrophy, urine or bowel incontinence, or pelvic pain, hereinafter collectively referred to as pelvic floor dysfunction; see for example: FALL, Magnus, Advantages and Pitfalls of Functional Electrical Stimulation, Acta Obstet Gynecol Scand 1998; Supplement 168: 77:16-21; and BO, Karl, Effect of Electrical Stimulation on Stress and Urge Urinary Incontinence, Acta Obstet Gynecol Scand 1998; Supplement 168: 77:3-11, both hereby incorporated herein by reference.
Currently, there are various probe designs that measure vaginal or rectal electromyographic (EMG) activity of the pelvic floor musculature. There are also several electrically conductive probes that deliver pulses of electrical energy aimed at depolarization and excitation of the nerves and muscle fibers of the pelvic floor and associated structures. The purpose of such stimulation is to help in the treatment of incontinence or pelvic pain. It is also known to provide electrically conductive electrodes in a probe for the dual purpose of either stimulation of, or recording, muscular activity (EMG) in the pelvic floor musculature. Generally, the probes to measure pressure are inflatable in order to establish intimate contact with the vaginal or rectal walls; and the probes for electrical stimulation or EMG recordings are constructed as rigid bodies.
There are several drawbacks in the existing probes. Having a rigid body presents a major disadvantage because the contracting muscles cannot shorten while contracting, and as a result they may not effectively stop the leakage. Inflating a pressure probe presents a similar disadvantage. Furthermore the rigid body of the probe does not permit an even contact with the irregular and highly variable surfaces of the vagina or rectum. These shortcomings may result in a very uncomfortable stimulation due to high current density.
Another deficiency in existing probes is the inability to measure the contractile force simultaneously with the application of electrical stimulation. Consequently neither the patient nor the clinician can determine how much if any contractile force is induced by the stimulation, and thus how effective is the stimulation. Measuring EMG during contraction may not correlate with the amount of contractile force, thus making it very difficult to quantify the strength of the pelvic floor musculature. Moreover, the known probes and stimulation EMG systems do no permit concurrent stimulation and EMG recording from the pelvic musculature. Finally, available pressure probes are not designed to conduct electricity and thus cannot be used simultaneously with electrical stimulation, a combination that may enhance significantly the recovery of muscle strength.
An object of the present invention is to provide a body-cavity probe having advantages in one or more of the above respects. Another object of the invention is to provide a method for utilizing such a probe in order to treat for any one of a plurality of pelvic floor dysfunctions.
According to one aspect of the present invention, there is provided a probe insertable into a body cavity for applying an electrical stimulation to tissue therein, comprising: a hollow member of flexible biocompatible material to enable the member to be inserted into the body cavity and to substantially conform to its inner surface, and thereby, to contact the tissue therein to be stimulated; at least a portion of the outer surface of the hollow member being electrically conductive to enable an electrical voltage to be applied thereto for electrically stimulating the tissue within the body cavity contacted by the electrically conductive surface.
More particularly, in the described preferred embodiments the hollow member includes at least two sections of electrically-conductive biocompatible material separated from each other by sections of electrically-insulating biocompatible material. Preferably, the hollow member is made of sections of electrically-conductive and electrically-insulating silicon resin.
According to further features in the described preferred embodiment, the hollow member is of tubular configuration, closed at one end and open at the opposite end to face the outer end of the body cavity to permit a fluid within the hollow member to be expelled, and thereby to permit the hollow member to substantially conform to the inner surface of the body cavity.
In the described preferred embodiments, the hollow member further includes a central spine of relatively stiff material extending through the interior of the hollow member. One end of the central spine includes a dome-shaped tip engaging the inner surface of the closed end of the hollow member, and the opposite end of the central spine includes a base secured to the open end of the hollow member. The base of the central spine includes an enlarged plate to be located externally of the body cavity and thereby to limit the penetration of the hollow member into the body cavity. The dome shaped tip of the central spine is electrically-conductive, and the closed end of the hollow member is also electrically-conductive. The central spine may be used for supporting the electrical conductors to the respective electrically-conductive sections of the hollow member.
According to still further features in the described preferred embodiments, the base includes a tube having one end communicating with the interior of the hollow member for the passage of fluids thereinto or therefrom, and an opposite end leading out of the hollow member and of the body cavity when the hollow member is inserted therein. The opposite end of the tube is connected to a fluid pressure measuring device for measuring the fluid pressure within the hollow member, and thereby the pressure applied to the hollow member by the tissue within the body cavity contacted by the hollow member.
The probe may also be used for inserting an optical sensor into the body cavity.
According to another aspect of the present invention, therefore, there is provided a probe insertable into a body cavity for sensing a condition therein, comprising: a hollow member of flexible biocompatible material such that the member, upon insertion into the body cavity, substantially conforms to the inner surface of the body cavity; at least a portion of the hollow member being optically transparent; and an optical sensor within the hollow member and aligned with the transparent section to optically sense a condition within the body cavity.
According to yet another aspect of the invention, there is provided a method of applying electrical stimulation to tissue within a body cavity, comprising: inserting into the body cavity a hollow member of flexible biocompatible material such that the hollow member substantially conforms to the inner surface of the body cavity and contacts the tissue therein to be stimulated, at least a portion of the outer surface of the hollow member being electrically conductive; and applying an electrical voltage to the electrically-conductive surface of the body member for electrically stimulating the tissue within the body cavity contacted by the electrically conductive surface.
According to a still further aspect of the invention, there is provided a method of sensing a condition of tissue within a body cavity, comprising: inserting into the body cavity a hollow member of flexible biocompatible material substantially conforming to the inner surface of the body cavity and thereby contacting the tissue therein whose condition is to be sensed, at least a portion of the hollow member being optically transparent, there being an optical sensor within the hollow member in alignment with the optically-transparent section; and utilizing the optical sensor for optically sensing a condition within the body cavity.
Further features and advantages of the invention will be apparent from the description below.